7 
Et. Mascxi said RAC has acted responsibly in the process of reviewing 
the Guidelines. He supported the need for IBCs in both academia and 
industry. Indeed this type of activity should not be limited to the 
recombinant ENA field but should be encouraged generically. He feared 
that RAC, by its endorsement for publication of the December 4, 1981, 
proposal, did not convey to the public the importance of IBCs. Dr. Mason 
suggested that certain issues should be carefully scrutinized, including 
deliberate release of reconabinant containing organisms into the environment 
and the cloning of genes for drug resistance and for certain toxins. 
Dr. Mason expressed the belief that the NIH Guidelines ultimately should 
and will become voluntary, but suggested they should remain mandatory for 
the time being for at least two reasons: (1) more information should be 
collected, particularly in regard to some of the areas currently prohibited; 
and (2) the public is not yet ready for volmtary guidelines. 
Dr. Goldstein said that he could not support the December 4 proposal. 
He said that he supports the December 7 proposal as it simplifies the 
Guidelines, specifies IBCs, and maintains mandatory Guidelines. He stated 
that haphazard local regulations, varying from ccmminity to cammmity, 
and hindering the research, will result if national oversight is not 
maintained. He felt the December 7, 1981, proposal does not deal ade- 
quately with large-scale work and that area should be reviewed. 
Ms. King noted that at the September 8-9, 1981, RAC meeting she had not 
supported v*iat became the December 4, 1981, proposal. She believes the 
December 7 "Gottesman" proposal is where the RAC should begin in trying 
to reach a final position. She expressed the belief that regulation is 
justified by concerns about safety. Arguments that recombinant ENA is no 
more dangerous than other forms of biomedical research have been advanced. 
This does not lead Ms. King to the conclusion that only a voluntary code 
of conduct is necessary. She suggested, rather, that if other research 
areas pose similar ri^, then perhaps they too should be regulated. She 
favored mandatory Guidelines with sanctions and a monitoring system. The 
structure should not yet be dismantled nor should it be made voluntary. 
Otherwise a system of fragmented regulations at the state and local level 
might develop. 
Mr. Thornton recognized Dr. Gottesman who had authored the December 7, 
1981, proposal. Er. Gottesman said her proposal is based on the assess- 
ment of risks in the document "Evaluation of the Rides Associated with 
Recombinant DNA" (46 FR 59385). She noted that that document had been 
generated by the Working Group on Itevision of the Guidelines during the 
summer of 1981. Ch the basis of that evaluation, she had concluded that 
there are several types of experiments about v^ich questions remain or 
about which so little is known that no absolute conclusion can be drawn. 
For these types of experiments she felt a mandatory record-keeping and 
oversight mechanism is ^pcopriate. 
Dr. Gottesman said her proposal requires RAC review and NIH approval for 
certain experiments involving toxin genes, drug resistance genes, and 
release into the envirOTment. Responsibility far cversight of certain 
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